Effect of Medium Chain Triglyceride Oil Supplementation in Mild Cognitive Impairment
Status: | Completed |
---|---|
Conditions: | Cognitive Studies |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/2/2016 |
Start Date: | August 2012 |
End Date: | October 2014 |
The primary aim of this study is to assess whether daily dosing with medium chain
triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive
performance.
triglycerides in subjects with mild cognitive impairment (MCI) will improve cognitive
performance.
Twenty eligible subjects will be enrolled in the study that will consist of a baseline visit
followed by six post-baseline visits. The control and placebo groups will each be comprised
of ten subjects randomly assigned to the groups. The assessments at baseline will include
concomitant medications, vital signs, height, and weight. In addition, subjects will
complete a medical history questionnaire, and receive group instruction on incorporation of
the study products into the diet from a registered dietitian. Study products will be
dispensed at each visit in excess of requirements, and re-issued at every visit after
measurement of the remaining product that subjects will be instructed to bring to every
visit. The post-baseline study visits will include body weight and vital sign measurements,
concomitant medications, dispensation of study products, group instruction by a registered
dietitian, and an assessment for adverse events.
Between study visits the subjects will receive a telephone call from the study coordinator
to encourage compliance with the diet, and to ask about any adverse events. The study visits
will conclude at week 24. The psychological tests conducted by clinicians at screening will
be repeated during the cognitive testing visit.
followed by six post-baseline visits. The control and placebo groups will each be comprised
of ten subjects randomly assigned to the groups. The assessments at baseline will include
concomitant medications, vital signs, height, and weight. In addition, subjects will
complete a medical history questionnaire, and receive group instruction on incorporation of
the study products into the diet from a registered dietitian. Study products will be
dispensed at each visit in excess of requirements, and re-issued at every visit after
measurement of the remaining product that subjects will be instructed to bring to every
visit. The post-baseline study visits will include body weight and vital sign measurements,
concomitant medications, dispensation of study products, group instruction by a registered
dietitian, and an assessment for adverse events.
Between study visits the subjects will receive a telephone call from the study coordinator
to encourage compliance with the diet, and to ask about any adverse events. The study visits
will conclude at week 24. The psychological tests conducted by clinicians at screening will
be repeated during the cognitive testing visit.
Inclusion Criteria:
1. Are male or female with a diagnosis of Mild Cognitive Impairment
2. Are 50 years of age or older
Exclusion Criteria:
1. Been on medication for Mild Cognitive Impairment less than 90 days
2. Major depression
3. Uncontrolled hypothyroidism
4. Known B12 deficiency
5. Hepatic (liver) disease or insufficiency
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